Dietary Supplement Recalls

A product recall can be one of the most upsetting and frustrating occurrences for a business. After all the time, effort and expense in getting a product to market, when a recall is necessary, the additional required time, effort and expenses can be exponential.

FDA requires a recall when an FDA-regulated product is either defective or potentially harmful. The recall may require removing the product from the marketplace entirely or taking corrective actions to fix the problem. Whether a recall is voluntary or required by FDA, it is FDA’s responsibility to oversee and confirm the adequacy of the process in order to protect the safety of the U.S. marketplace.

Prior to the Food Safety Modernization Act (FSMA), FDA was first notified of a potential problem that may require a recall when:

A company discovered a problem and contacted FDA.

FDA inspected a manufacturing facility and determined the potential for a recall.

FDA received reports of health problems.

Or, the Centers for Disease Control and Prevention (CDC) contacted FDA.

With the passage of the FSMA, FDA now requires firms to take a much more proactive approach with the safety of their products. From ingredient suppliers, to manufacturing and processing to the transportation of the products to the U.S. marketplace, this proactive approach is intended to prevent harm before it occurs and in turn hopefully require fewer recalls.

EAS Consulting Group, LLC. can help with recall prevention strategies through audits of Good Manufacturing Practices (GMPs), review of labeling and health or disease claims on packaging and marketing materials as well ingredient and toxicology reviews and appropriate filings and documentations. EAS can also assist with the performance of a mock recall to assess your readiness to execute an actual recall.

In the unfortunate event of a recall, EAS consultants can help walk your company through the steps of the recall process to ensure FDA compliance. Whether the infraction is a Class I, II or III recall, EAS can assist in making this challenging process more streamlined and act as a conduit of information between your company and FDA.